| Product NDC: | 52584-038 |
| Proprietary Name: | KETAMINE HYDROCHLORIDE |
| Non Proprietary Name: | ketamine hydrochloride |
| Active Ingredient(s): | 50 mg/mL & nbsp; ketamine hydrochloride |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52584-038 |
| Labeler Name: | General Injectables & Vaccines, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA074549 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121011 |
| Package NDC: | 52584-038-10 |
| Package Description: | 1 VIAL in 1 BAG (52584-038-10) > 10 mL in 1 VIAL |
| NDC Code | 52584-038-10 |
| Proprietary Name | KETAMINE HYDROCHLORIDE |
| Package Description | 1 VIAL in 1 BAG (52584-038-10) > 10 mL in 1 VIAL |
| Product NDC | 52584-038 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ketamine hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20121011 |
| Marketing Category Name | ANDA |
| Labeler Name | General Injectables & Vaccines, Inc |
| Substance Name | KETAMINE HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | General Anesthesia [PE],General Anesthetic [EPC] |